FDA
The Food and Drug Administration (FDA), the US medical device regulating authority, has published a notice dedicated to the pilot program for a request for designation (RFD) and pre-request for designation (Pre-RFD) electronic submissions. The document was published...
Europe
MedTech Europe, a European association of medical device manufacturers and other industry representatives, has published a call to action related to the virtual inspections of the manufacturing facilities. Virtual Audits: Regulatory Background First of all, it is...
FDA
The Food and Drug Administration (FDA) has published an updated fee schedule for medical device users – the companies applying for FDA approval for their medical devices. According to the Medical Device User Fee Amendments (MDUFA), most of the entities...
Europe
Swissmedic, a Swiss authority responsible for medical device regulations, has published an information sheet dedicated to the marketing authorization of non-conforming medical devices. In particular, the document describes the rules and procedures to be applied for...
FDA
The Food and Drug Administration (FDA) has published a guidance document dedicated to providing regulatory submissions for medical devices in the electronic format under Section 745A(b) of the Federal Food, Drug, and Cosmetic Act (FD&C Act). Submissions in...
